An observational study in Angioedema, Angioedemas, Hereditary and Urticaria, sponsored by Foundation For Rare Disease Research. Recruiting at 1 site in United States. Open to participants aged 12 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Foundation For Rare Disease Research · Observational
This clinical trial aims to evaluate and compare novel and commercially available diagnostic assays through blood tests for the differential diagnosis and comprehensive assessment of patients experiencing recurrent angioedema attacks, including both urticarial and non-urticarial angioedema. The primary objective is to assess the efficiency of novel diagnostic assays, both individually and in combination, in comparison to currently available commercial tests. The ultimate goal is to establish the feasibility of developing an affordable and accurate laboratory test capable of diagnosing the diverse etiological manifestations of angioedema.
Purpose: The purpose of this prospective non-interventional non-randomized diagnostic study is to first identify patients with recurrent angioedema attacks, then collect their blood samples (venipuncture) and ultimately send the samples to specialized laboratories to perform multiple diagnostic assays, novel and traditional, that can distinguish the various forms of angioedema (urticaria and non-urticarial symptoms and signs), and healthy subjects.
Methods and Materials: Blood specimen collection from a total of 300 patients with recurrent angioedema attacks, and 300 healthy volunteers without a history of angioedema attacks. Laboratory testing will include assays on multiple platforms. Complement testing via immunoassay and biochemistry techniques. Flow Cytometry using multiple markers. Mass Spectrometry that includes bradykinin metabolite and histamine detection. Molecular Genetics include Sanger sequencing, Next Generation Sequencing (NGS), and digital PCR.
Patient population: Study participants to be screened who have a history of recurrent angioedema incidents as well as a population of healthy subjects. A medical history will be documented after obtaining informed patient consent to enter into the clinical trial. Each enrolled participant will have blood collected as whole blood, plasma and serum via venipuncture.
Eligibility criteria (inclusion) for sample collection (angioedema subject):
Eligibility criteria (inclusion) for sample collection (for healthy participant/subject):
Exclusion Criteria (for all participants):
171 studies on the registry are indexed under Angioedemas, Hereditary; 24 are open to participants now.
This study's planned enrollment of 600 is above the median of 100 across 43 observational studies indexed under Angioedemas, Hereditary.
Browse Angioedemas, Hereditary studies →This is the only study on the registry with Foundation For Rare Disease Research as lead sponsor.
Compared within Angioedemas, Hereditary, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Angioedema. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The collection of medical history and peripheral blood (venipuncture) to perform multiple diagnostic assays from patients experiencing recurrent angioedema attacks, including both urticarial and non-urticarial angioedema. Healthy volunteers will not have a medical history of angioedema.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Broad definition: Angioedema due to urticaria (histaminergic/mast-cell) or non-urticarial (non-histaminergic) etiology Narrow definition: non-urticarial angioedema - distinguishing between C1-Inhibitor deficiency/dysfunction, and Angioedema with normal levels of C1-Inhibitor.
Diagnostic Test: Venipuncture
Broad definition: No medical history of angioedema of any kind, including urticaria (histaminergic) or drug-induced angioedema (e.g. ACE-Inhibitor angioedema)
Diagnostic Test: Venipuncture
venipuncture
Novel versus traditional diagnostic blood test for angioedema
Determining whether novel test methods can be more efficient than currently available or traditional laboratory test for angioedema diagnosis
Time frame: 2 years
Genetic analysis of angioedema versus non-angioedema affected populations
Genetic testing that include know angioedema mutations, such as SERPING1
Time frame: 2 years
Development of novel Bradykinin biomarkers
Mass Spectrometry analysis of plasma for bradykinin metabolites
Time frame: 2 years
Immunoassay laboratory developed tests for angioedema
development of novel immunoassay biomarkers, such as the detection of cleaved HMWK
Time frame: 2 years
Lymphocyte profile studies
Determine whether the immune system has a role in angioedema attacks
Time frame: 2 years
Plan to share: Yes — The analyzed data will be published in a peer-reviewed journal and preliminary results published on clinicaltrials.gov website
Supporting information: Study protocol, Clinical study report
Time frame: 2 years
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Jul 2027, 42 months after the start.
Of 27 observational studies under Angioedemas, Hereditary, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 56. This study's planned 42 months is close to that.
How these figures are worked out, and which studies are left out of them.
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